- Chicago drugmaker AbbVie Inc. said Monday a Phase 3 study combining its leukemia drug Venclexta with Roche AG's Rituxan extended progression-free survival in patients with resistant chronic lymphocytic leukemia (CLL) who have relapsed after prior treatment.
- While no specifics were unveiled, the positive results could help the two companies — which jointly commercialize Venclexta in the U.S. — expand the addressable market for the drug beyond the narrow slice of CLL patients it is currently approved to treat.
- "This is the first study to show that Venclexta/Venclyxto plus Mabthera/Rituxan can help people with this type of leukaemia live significantly longer without their disease worsening compared to a standard-of-care regimen," said Sandra Horning, Roche's chief medical officer in a statement.
Best known for its mega-blockbuster Humira, AbbVie has made a concerted effort to expand its reach in oncology — a therapeutic area certainly not hurting for lack of competition.
The drugmaker's $21 billion acquisition of Pharmacyclics in 2015 has started to pay off, as sales of Imbruvica (ibrutinib) continue to grow rapidly. The drug, approved in CLL as well as several lymphomas and graft-versus-host disease, earned $1.2 billion through the first six months of the year.
Venclexta (venetoclax) should complement Imbruvica, potentially adding depth in later lines of CLL treatment and building a broader foundation in blood cancer. The MURANO study is the first major step towards that goal, following the drug's initial approval in a subset of CLL patients with a chromosomal defect known as 17p deletion.
These patients are less likely to respond to chemotherapy of Rituxan (rituximab) and face a grimmer prognosis than the majority of patients with CLL. While a narrow subset of the overall CLL population, 17p deletion is present in between 30% to 50% of relapsed/refractory patients.
MURANO combines Venclexta with Rituxan in hopes of addressing that larger remaining portion of the relapsed/refractory market. Compared to the chemotherapy bendamustine, adding Venclexta to Rituxan therapy significantly lengthened progression-free survival.
An independent data monitoring committee recommended unblinding the study after seeing the combo's positive effect at an interim analysis. AbbVie said safety data are currently being analyzed, although Roche indicated in its statement there were no new safety signals.
Treatment with Venclexta does come with the potentially dangerous side effect of tumor lyis syndrome — which prompted the Food and Drug Administration to recommend phophylactic treatment and monitoring based on patient tumor burden in the drug's label.
Full data will be presented at an upcoming medical meeting and will be the basis for a subsequent regulatory submission for approval in all relapsed/refractory CLL patients.